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Late Phase II Study of TS-142 in Patients With Insomnia

Primary Purpose

Patients With Insomnia

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

TS-142

About this trial

This is an interventional treatment trial for Patients With Insomnia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Japanese male and female age 20 years or older at the time of informed consent
Outpatients
Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1
Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1
Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety
Other protocol defined exclusion criteria could apply

Sites / Locations

Taisho Pharmaceutical Co., Ltd selected site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

TS-142 2.5 mg

TS-142 5 mg

TS-142 10 mg

Placebo

Arm Description

Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime

Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime

Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime

Period in which participants received single placebo prior to bedtime

Outcomes

Primary Outcome Measures

LS mean difference from placebo; Change between baseline and end of the study of sSL

sSL is defined as the duration of time that it took to fall asleep as recorded in a sleep diary

Secondary Outcome Measures

LS mean difference from placebo; Change between baseline and end of the study of sTST

sTST is defined as the total amount of time spent asleep before getting-out from his/her bed for the day as recorded in a sleep diary

LS mean difference from placebo; Change between baseline and end of the study of sWASO

sWASO is defined as the total amount of time spent awake after falling asleep and before getting-out from bed for the day as recorded in a sleep diary.

Full Information

NCT ID

NCT04469023

First Posted

July 8, 2020

Last Updated

October 4, 2022

Sponsor

Taisho Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04469023

Brief Title

Late Phase II Study of TS-142 in Patients With Insomnia

Official Title

Late Phase II Study of TS-142 in Patients With Insomnia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

September 9, 2020 (Actual)

Primary Completion Date

November 16, 2021 (Actual)

Study Completion Date

November 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taisho Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group exploratory study in patients with insomnia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

179 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TS-142 2.5 mg

Arm Type

Experimental

Arm Description

Period in which participants received multiple-dose of 2.5 mg TS-142 prior to bedtime

Arm Title

TS-142 5 mg

Arm Type

Experimental

Arm Description

Period in which participants received multiple-dose of 5 mg TS-142 prior to bedtime

Arm Title

TS-142 10 mg

Arm Type

Experimental

Arm Description

Period in which participants received multiple-dose of 10 mg TS-142 prior to bedtime

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Period in which participants received single placebo prior to bedtime

Intervention Type

Drug

Intervention Name(s)

TS-142

Intervention Description

Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)

Primary Outcome Measure Information:

Title

LS mean difference from placebo; Change between baseline and end of the study of sSL

Description

sSL is defined as the duration of time that it took to fall asleep as recorded in a sleep diary

Time Frame

Baseline and Week 2

Secondary Outcome Measure Information:

Title

LS mean difference from placebo; Change between baseline and end of the study of sTST

Description

sTST is defined as the total amount of time spent asleep before getting-out from his/her bed for the day as recorded in a sleep diary

Time Frame

Baseline and Week 2

Title

LS mean difference from placebo; Change between baseline and end of the study of sWASO

Description

sWASO is defined as the total amount of time spent awake after falling asleep and before getting-out from bed for the day as recorded in a sleep diary.

Time Frame

Baseline and Week 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Japanese male and female age 20 years or older at the time of informed consent Outpatients Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder Other protocol defined inclusion criteria could apply Exclusion Criteria: Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1 Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1 Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety Other protocol defined exclusion criteria could apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taisho Director

Organizational Affiliation

Taisho Pharmaceutical Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Taisho Pharmaceutical Co., Ltd selected site

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Late Phase II Study of TS-142 in Patients With Insomnia

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